Diabetes Clinical Trial
Official title:
The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products
Single-center open-label multiple dose randomized two period cross-over study to examine Advanced Glycation End Product (AGE) levels in human subjects pre and post empagliflozin administration.
Single-center open-label multiple dose randomized two period cross-over study.
The North-Shore Long Island Jewish Institutional Review Board will be used to approve our
study protocol.
All patients will give written informed consent and comply with the Helsinki agreement and
good clinical practices guidelines.
Treatment Plan:
Eligible patients will be randomized to receive linagliptin 5mg daily or empagliflozin 25mg
daily for 30 days followed by a 30 day washout period and crossover. All pre-existing
diabetic medications will continue unchanged.
Fasting blood carboxymethyl lysine (CML), methylglyoxal (MG), vascular cell adhesion molecule
(VCAM), tumor necrosis factor (TNF) alpha, 8-isoprostane, and routine chemistries and urinary
CML, MG, and creatinine will be measured at baseline, after 30 days, 60 days and 90 days.
AGE levels will be measured by Elisa.
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